Components and kits for collecting, securing, identifying and tracking unique samples

ABSTRACT

The present specification discloses sample containers and collection kits for collecting a sample being handled by a chain-of-custody protocol and methods and uses for collecting a sample using such sample containers and collection kits.

Chain-of-custody (CoC) is a record that chronologically documents thesequence of procurement, custody, control, transfer, analysis,disposition, management and storage of physical and/or electronicevidence. This procedure requires clear, complete and conciseinformation of a sample, each person who handled the sample, and theresults obtained from analyzing the sample for the entire phase oftesting, from the moment an individual provides a sample to a collectorto the final destination of the sample and the review and reporting ofthe final test result.

Whether mandated by legal regulations or enacted as a best practiceprocedure, one of the main purposes of tracking a sample using a CoCprotocol is to protect the integrity of the sample. For example, thereare many circumstances that may lead to drug testing includingpre-employment evaluation, work-related assessment, college orprofessional athletic monitoring, post-accident investigations, andsafety-related appraisals. As a positive drug test result for acontrolled substance has adverse consequences for the subject it isimperative that strict chain-of-custody (CoC) practices and standardsare in place to prevent adulteration or contamination of a biologicalsample. Similarly, during investigation of a crime scene, evidence isroutinely collected in an effort to elucidate what happened and helpapprehend the person or persons responsible for the crime. Strictchain-of-custody (CoC) practices of biological and/or non-biologicalsamples collected at a crime scene is essential to ensure that suchevidence can be authenticated and used in a court of law in order tohelp determine the guilt or innocence of a person accused of the crime.CoC protocols are also useful regarding the collection of samples forscientific research ranging from pharmaceutical drug development toarcheological investigation, ecological and environmental evaluations ofpollutants, or any other situation where complete information regardingthe collection, transportation and analysis of a sample is desired.

The problems associated with current CoC protocols can be exemplifiedusing random drug testing policies as a non-limiting example. Due toconcerns of public safety regarding illegal drug use in the workplace,random drug testing is becoming more prevalent in our society.Currently, such testing is mandated by the federal government in manyindustrial sectors such as transportation, law enforcement and themilitary. For example, Department of Transportation (DOT) mandates thatall companies governed by 49 C.F.R. Part 40 randomly test allsafety-sensitive employees for drug and alcohol use. Typically, anemployee is informed upon his arrival at work that he/she was randomlyselected for drug testing. A sample is immediately collected at his/herplace of employment. When the sample being collected is urine, thesample is collected in the presence of another company employee hired toperform this duty (i.e., a collector). Usually, the collection isperformed in a lavatory facility on-site. The employee follows theprovided instructions and ultimately aliquots the sample from acollection container into two testing containers. Besides observing thecollection of the sample, the collector will also record informationnecessary for the proper testing of the sample and oversee thetransportation of the testing containers containing the sample to atesting facility.

Currently there are various ways a collector record information on anemployee being drug tested. In one in particular, the collector will usea five-part, carbon copy CoC form and writes all required information onthis form. Besides identifying information on the employee, this formalso indicates the type of testing to be performed including thesubstances to be tested. This CoC form also includes a duplicate barcode label for tracking purposes. The collector will peel off one of thebar code labels and affix to one of the testing containers and then takethe second label and affix to the second testing container. Once the CoCform is completed and the containers labeled with the bar code, thecollector will package up the material and send to a laboratory testingfacility for analysis.

In another approach, the collector will manually enter the requiredinformation regarding the employee and testing requirements into asoftware program that will store and send the recorded informationelectronically to the laboratory testing facility. This software alsogenerated a duplicate bar code label which is printed on standard sheetor labels at the place where the sample for testing is collected. Onceprinted, the bar code labels are affixed to both testing containers asdescribed above. The collector will package up the containers and sendto a laboratory testing facility for analysis.

There are several problems associated with the current CoC procedures.For example, use of the five-part, carbon copy CoC form is cumbersomeand time consuming, involves great expense to print and ship to acompany, and uses company resources to store and manage the forms.Similarly, current software application require the bar code label to beprinted separately, which for CoC requirements must be done at the siteof collection. This is commonly a general-purpose lavatory used by allemployees. Such an awkward arrangement leads to chronic malfunction ofthe printer, disruptions due to paper or ink shortages, and uneasinessof the employee, the collector and other co-workers.

As such, new kits and methods are needed that address the shortcomingsdiscussed above as well as improve the accuracy and efficiency of thecurrent CoC procedures

SUMMARY

The present specification discloses a collection container, a collectionkit and methods associated with each that addresses the above problemsas well as others known in the field and increases the integrity of theCoC procedure ensuring the fidelity of a sample and more accurate andvalid test results. In addition, the disclosed collection container,collection kit and associated methods improve the collection andhandling of any sample that is difficult to handle due to thecomposition of the sample or due to require safety precautions make itdifficult to handle the sample.

Aspects of the present specification discloses a kit for collecting asample. The disclosed collection kit comprises an identification label.The collection kit may also contain a sample collection device, one ormore sample containers, a collecting pouch, instructions pertaining tothe use of the kit and/or collection of the sample, a cleaning wipe, orany combination thereof.

Aspects of the present specification discloses a sample container for asample. The disclosed sample container comprises an identificationlabel. In aspects, the identification label has a portion associatedwith the sample container, preferably a lid and one or more portionsunassociated with the sample container. The one or more unassociatedportions have the adhesive side of the identification label covered witha protective covering that optionally comprises tabs for easy removal.Once a sample is dispensed into the sample container, the lid issecured, the protective covering of the one or more unassociatedportions of the identification label are removed, and the one or moreunassociated portions are secured to the side of the sample container.

Other aspects of the present specification disclose a method or use forcollecting a sample. The disclosed method comprising collecting a sampleusing a collection kit disclosed herein and affixing a machine readableprovided by the disclosed kit to each of the one or more samplecontainers comprising a sample. The method can also include associatinginformation on the originating source of the sample and/or testinginstructions with the identification label.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 shows an exemplary embodiment of a collection kit 10 disclosedherein.

FIGS. 2A-B show a front perspective view of a sample collection device12 disclosed herein.

FIGS. 3A-B show an exemplary embodiment of a sample container 30disclosed herein with FIG. 3A showing a front perspective view of samplecontainer 30 with lid 34 closed; FIG. 3B showing a front perspectiveview of sample container 30 with lid 34 open.

FIGS. 4A-G shows an exemplary embodiment of an identification label 20disclosed herein with FIG. 4A showing top plan view of identificationlabel 20 illustrating label side 22 with three differentmachine-readable codes 24; FIG. 4B showing top plan view ofidentification label 20 illustrating label side 22 with two differentmachine-readable codes 24; FIG. 4C showing bottom plan view ofidentification label 20 illustrating adhesive side 26 with protectivecovering 28 and tab 29; FIG. 4D showing side elevational view ofidentification label 20; FIG. 4E showing top plan view of identificationlabel 20 secured to lid 34; FIG. 4F showing bottom plan view ofidentification label 20 secured to lid 34; and FIG. 4G showing sideelevational view of identification label 20 secured to lid 34.

FIG. 5 shows an exemplary embodiment of a collecting pouch 40 disclosedherein.

FIG. 6 shows an exemplary embodiment of a cleaning wipe 50 disclosedherein.

FIGS. 7A-B show an exemplary embodiment of a sample container 30disclosed herein with FIG. 7A showing a front perspective view of samplecontainer 30 with lid 34 closed and identification label 20 affixed;FIG. 7B showing a front perspective view of sample container 30 with lid34 open and identification label 20 torn to indicate lid 34 was opened.

FIG. 8 shows an exemplary embodiment of a sealed collecting pouch 40disclosed herein containing two sample containers 30 each affixed withan identification label 20.

FIG. 9 shows an exemplary embodiment of a collection kit 100 disclosedherein.

FIGS. 10A-B show an exemplary embodiment of a sample shipping container80 disclosed herein with FIG. 10A showing view of front side elevationalview of sample shipping container 80; and FIG. 10B showing view of backside elevational view of sample shipping container 80.

FIGS. 11A-B show an exemplary embodiment of a sample container 130disclosed herein with FIG. 11A showing a side view of sample container130; and FIG. 11B showing a top view of sample container 130 with asample.

FIG. 12 shows an exemplary embodiment of a collecting pouch 140disclosed herein.

FIG. 13 shows an exemplary embodiment of a cleaning wipe 150 disclosedherein.

DETAILED DESCRIPTION

The present specification discloses a kit for collecting a samplecomprises one or more components. In one embodiment, a collection kitdisclosed herein can include one or more identification labels and oneor more sample containers. In another embodiment, a collection kitdisclosed herein can include one or more identification labels, one ormore sample containers, and a sample collection device. In anotherembodiment, a collection kit disclosed herein can include one or moreidentification labels, one or more sample containers, and a sampleshipping container. A collection kit disclosed herein may also include acollecting pouch. A collection kit disclosed herein may also includeinstructions pertaining to the use of the kit, instructions pertainingto the collection of the sample, or both. Such instructions can beprovided together or provided as separate instructions. Additionally, acollection kit disclosed herein can contain a cleaning wipe.

In an embodiment, a collection kit disclosed herein is assembled so thatthe sample collection device servers as a container for the remainingcomponents of the kit. In aspects of this embodiment, and referring toFIG. 1 , a collection kit 10 comprises a sample collection device 12which serves as a container and one or more identification labels 20. Inother aspects of this embodiment, a collection kit 10 comprises a samplecollection device 12 which serves as a container and one or moreidentification labels 20 and one or more sample containers 30. In yetother aspects of this embodiment, a collection kit 10 comprises a samplecollection device 12 which serves as a container and one or moreidentification labels 20, one or more sample containers 30 and acollecting pouch 40. In still other aspects of this embodiment, acollection kit 10 comprises a sample collection device 12 which servesas a container and one or more identification labels 20, one or moresample containers 30, a collecting pouch 40 and instructions. In furtheraspects of this embodiment, a collection kit 10 comprises a samplecollection device 12 which serves as a container and one or moreidentification labels 20, one or more sample containers 30, a collectingpouch 40, instructions and a cleaning wipe 50. In some embodiments,sample collection device 12 is secured in a manner to prevent the othercomponents from falling out or being removed until needed, such as byemploying a plastic lid, a seal like an aluminum foil seal or a plasticseal, or other covering. For example, FIG. 1 shows a seal 14 (partiallypulled away in this illustration) used to seal sample collection device12 in a manner that prevents the other components from falling out orbeing removed until needed.

In another embodiment, collection kit disclosed herein is assembled sothat a collecting pouch serves as a container for the remainingcomponents of the kit. A collecting pouch disclosed herein is secured ina manner to prevent the other components from falling out or beingremoved until needed, such as by employing the flap of a collectingpouch. In an aspect of this embodiment, and referring to FIG. 9 ,collection kit 100 comprises collecting pouch 140 which serves as acontainer and one or more identification labels 120, one or more samplecontainers 130, and sample shipping container 80. In another aspect ofthis embodiment, a collection kit 100 comprises collecting pouch 140which serves as a container and one or more identification labels 120,one or more sample containers 130, sample shipping container 80, andinstructions. In yet another aspect of this embodiment, a collection kit100 comprises collecting pouch 140 which serves as a container and oneor more identification labels 120, one or more sample containers 130,sample shipping container 80, and cleaning wipe 150. In still anotheraspect of this embodiment, a collection kit 100 comprises collectingpouch 140 which serves as a container and one or more identificationlabels 120, one or more sample containers 130, sample shipping container80, cleaning wipe 150, and instructions. In some embodiments, collectingpouch 140 is secured in a manner to prevent the other components fromfalling out or being removed until needed, such as by an adhesive, aperforated seal that can be pulled off to enable access to the contentswithin or a zip-lock seal. For example, FIG. 9 shows a perforated top146 is used to seal collecting pouch 140 in a manner that prevents theother components from falling out or being removed until needed.

Aspects of the present specification disclose a sample collectiondevice. A sample collection device disclosed herein is used to collect asample for subsequent evaluation from an individual, mechanical purpose,forensic site or anywhere a trackable container is useful or required.Although such a device can be used to transport the sample to a testingfacility, a sample collection device is primarily used to collect asample from an individual and then dispense an aliquot of the sample tothe one or more sample containers. A sample collection device disclosedherein can be of any size and geometry but should be designed so that itis larger enough to collect an adequate amount of a sample from anindividual for testing purposes and small enough to make manufacture,assembly, transportation, and storage convenient to the user. In anaspect of this embodiment, a sample collection device has a cylindricalcup-shaped design with a capacity to hold between 100 mL to 400 mL. Inone embodiment, and referring to FIGS. 3A-B, a sample collection device20 has a cylindrical cup-shaped design with a capacity to hold between200 mL to 250 mL. Once a sample is dispensed to the one or more samplecontainers, a sample collection device, as well as any remaining samplecan be disposed. As discussed above, a sample collection devicedisclosed herein can also function as an assembly container for theremaining components of a collection kit disclosed herein.

Aspects of the present specification disclose a sample shippingcontainer. A sample shipping container is used to transport a samplecontainer comprising a sample to a testing facility. A sample shippingcontainer disclosed herein can be of any size and geometry but should bedesigned so that it is larger enough to receive one or more samplecontainers and small enough to make manufacture, assembly,transportation, and storage convenient to the user. A sample shippingcontainer includes, without limitation, an envelope, canister mailingpouch, or a mailing box. In an aspect of this embodiment, and referringto FIG. 10A-B, a sample shipping container is an envelope 80 with frontside 82 including sealing flap 86 and rear side 84.

Aspects of the present specification disclose a sample container. Asample container disclosed herein is used to save and seal foridentification and tracking purposes a sample disclosed herein oraliquot thereof immediately after collection as well as duringtransportation, testing and storage. A sample container disclosed hereincan be composed from any inert material suitable to store a sampledisclosed herein, including without limitation a glass, metal or aplastic material. A sample container disclosed herein can be of any sizeand geometry but should be designed so that it is larger enough tocontain an adequate amount of a collected sample from an individual fortesting or further evaluation purposes and small enough to makemanufacture, assembly, transportation, and storage convenient to theuser. In an embodiment, a sample container disclosed herein should be ofa size and geometry to fit the desired number of sample containers intoa sample collection device disclosed herein during assembly. In aspectsof this embodiment, a sample container may have a cylindrical shape andcorresponding closure with a capacity to hold between 10 mL to 60 mL. Inaspects of this embodiment, a sample container is a flat sheet ofmaterial having a width of 2 cm to 6 cm and a length of 9 cm to 14 cm.

In one embodiment, and referring to FIGS. 3A-B, a sample container 30comprises a container 32 and a lid 34. A container 32 disclosed hereinis used to contain a sample or aliquot thereof. In an aspect of thisembodiment, a sample contained in sample container 30 can be a liquid ora solid sample. A lid 34 disclosed here is used to seal the container ina manner that prevents sample leakage or contamination during, e.g.,transportation and storage. For example, as illustrated in FIGS. 3A-B,sample container 30 can comprise a locking mechanism 36 that secures lid34 to container 32 in a manner that prevents its opening unless lockingmechanism 36 is released. In aspects of this embodiment, samplecontainer 30 has a cylindrical design with a capacity to hold between 20mL to 40 mL. In typical use, after a sample is collected in a samplecollection device 12 disclosed herein, an aliquot of the sample isdispersed into a sample container 30 disclosed herein and then sealedwith the lid 34.

A lid 34 can also be a tamper-proof design, thereby assuring that thesample container has been sealed since manufacture and thus unlikely tohave been contaminated or adulterated. For example, as illustrated inFIGS. 7A-B, identification label 20 can be secured in a manner wherebyin the process of opening lid 34 identification label 20 is torn orotherwise disfigured in a manner that indicates sample container 30 wasopened.

In another embodiment, and referring to FIG. 11A-B, a sample container130 comprises a malleable or pliable, non-elastic material used to wrapor otherwise contain a sample, such as, e.g., a metal or plasticmaterial. In another aspect of this embodiment, sample container 130 canbe aluminum. In aspects of this embodiment, sample container 130 is aflat sheet of aluminum having a width of about 3 cm to 4 cm and a lengthof 10 cm to 11 cm. In another aspect of this embodiment, a sample 70contained in sample container 130 can be a solid sample. In operation, asample is place on one side of sample container 130, typically in acentral location, and then sample container 130 is folded onto itself ina manner that wraps or otherwise contains a sample.

A sample container disclosed herein can be provided as a separatecomponent or a component included in a collection kit disclosed herein.When provided as a separate component, an identification label will beassociated with a sample container as an integrated component. Forexample, referring to FIG. 4E-G, identification label 20 is associatedwith lid 34.

The number of sample containers comprising a collection kit disclosedherein depends of the particular use and CoC requirements. Thus, in oneembodiment, a kit disclosed herein comprises one sample container. Inanother embodiment, a collection kit disclosed herein comprises aplurality of sample containers. In yet another embodiment, a collectionkit disclosed herein can comprise, e.g. one or more sample containers,two or more sample containers, three or more sample containers, four ormore sample containers, or five or more sample containers. In stillanother embodiment, a collection kit disclosed herein can comprise, e.g.at most one sample container, at most two sample containers, at mostthree sample containers, at most four sample containers, or at most fivesample containers. In still another embodiment, a collection kitdisclosed herein can comprise, e.g. 1-2 sample containers, 1-3 samplecontainers, 1-4 sample containers, 1-5 sample containers, 2-3 samplecontainers, 2-4 sample containers, 2-5 sample containers, 3-4 samplecontainers, 3-5 sample containers, or 4-5 sample containers.

Aspects of the present specification disclose an identification label.An identification label disclosed herein is a medium capable of storingand displaying data in a format readable by a mechanical device.Referring to FIGS. 4A, 4B, & 4E, an identification label 20 disclosedherein comprises a label side 22 on one side having a machine-readablecode 24 and an adhesive side 26 of the other side. Referring to FIGS.10A-B, an identification label 120 disclosed herein comprises a labelside 122 on one side having a machine-readable code 124 and an adhesiveside 126 of the other side. A machine-readable code disclosed herein hasunique identification characteristics. Non-limiting examples ofmachine-readable code 24, 124 include a bar code, a matrix code ortwo-dimensional bar code, a radio frequency identification (RFID), amagnetic strip, a microchip, and an optical character recognition (OCR).

In some embodiments, an identification label consists of a singleidentification label. In aspects of this embodiment, identificationlabel can comprise a single machine-readable code. In other aspects ofthis embodiment, identification label can comprise more than onemachine-readable codes. For example, as shown in FIG. 4B, identificationlabel 20 consists of a single identification label 20 with label side 22including two machine-readable codes 24, e.g., one bar code 21 and oneOCR 25. As another example, as shown in FIG. 11A, identification label120 consists of a single identification label 120 with label side 122including two machine-readable codes 124, e.g., one bar code 121 and oneOCR 125.

In some embodiments, identification label consists of more than oneidentification labels. In aspects of this embodiment, each of the morethan one identification labels can comprise a single machine-readablecode. In other aspects of this embodiment, each of the more than oneidentification labels can comprise more than one machine-readable codes.For example, as shown in FIG. 4A, identification label 20 consists of afirst identification label 20′ and second identification label 20″. Thefirst identification label 20′ comprises a label side 22′ including onemachine-readable code 24, e.g., bar code 21′ while the secondidentification label 20″ comprises a label side 22″ including more thanone machine-readable codes 24, e.g., bar code 21″ and OCR 25. In thisarrangement, a first component can be affixed with first identificationlabel 20 while a second component can be affixed with secondidentification label 20. For example, first identification label 20′comprising a label side 22′ including one machine-readable code, e.g.,bar code 21′ can be affixed to collection pouch 40 from collection kit10 while second identification label 20″ comprising label side 22″including two machine-readable code, e.g., bar code 21″ and OCR 25 canbe affixed to sample container 30.

Typically an automatic identification and data capture (AIDC) method isemployed to read the code in order to automatically identify the sample,collecting data about the sample, and enter the data directly intocomputer systems, without human involvement. An identification labeldisclosed 20 herein enables CoC procedures by tracking the one or moresample containers containing a sample throughout the entire process. Theidentification label tracks, for example, the chronological record of asample, identifying information of the originating source of the sample,such as, e.g., the individual who donated the sample, the apparatus orlocation from where the sample was obtained, each person who collectedand/or handled the sample, and the results obtained from analyzing thesample.

Referring to FIGS. 4A & 4C, adhesive side 26 of an identification label20 comprises an adhesive (not shown) and a protective covering 28. Anadhesive can cover all or a portion of adhesive side 26 and is used toaffix identification label 20 to sample container 30. A protectivecovering 28 shields or otherwise prevents the adhesive from debris,inappropriate affixing or other events fouling or otherwise making theadhesive inoperable for its intended use. In some embodiments, and asbest seen in FIG. 4A, protective covering 28 is a simple sheet. In someembodiments, and as best shown in FIGS. 4C, 4D & 4G protective covering28 can comprise one or more tabs 29. As a user of a collection kitdisclosed herein will in all likelihood be wearing protective gloves tothe handling of a sample, tab 29 facilitates easy removal of protectivecovering 28 from adhesive side 26 of identification label 20 in order toexpose an adhesive. Containers having an integrated identification labelenable serialization of machine-readable codes in consecutive order thatfacilitate data reporting and tracking with respect to inventory usage.In an aspect of this embodiment, a collection kit disclosed hereincontains a plurality of containers each having an integratedidentification label serialization with machine-readable codes inconsecutive order.

In one embodiment, an identification label can be a component separatefrom the other components including a sample container. For example,FIGS. 1 & 4A-D illustrate identification label 20 as a componentseparate from the other components including a sample container. Once asample is aliquoted to container 32 of a sample container 30 disclosedherein it is sealed using lid 34. Identification label 20 is thenaffixed to the sample container by removing protective covering 28 onadhesive side 26 of identification label 20 to expose an adhesive.Identification label 20 is then secured to sample container 30 byplacing identification label 20 adhesive side down across lid 34 anddown at least one side of container 32 (FIG. 7 ).

In another embodiment, an identification label is associated with asample container as an integrated component. In aspects of thisembodiment, an identification label is associated with a lid of a samplecontainer. For example, referring to FIG. 4E-G, identification label 20is associated with lid 34 and identification label 20 has one or moreportions that remain unassociated with lid 34. Adhesive side 26 of theone or more unassociated portions of identification label 20 are coveredwith protective covering 28 that can optionally comprise one or moretabs 29. Once a sample is aliquoted to container 32 of sample container30 disclosed herein it is sealed using lid 34. Protective covering 28 isremoved from the one or more unassociated portions of identificationlabel 20 to expose adhesive side 26. The one or more unassociatedportions of identification label 20 are then affixed to the sides of asample container. One or more sides of identification label 20comprising adhesive is then secured to sample container 30 by placingthe one or more sides of identification label 20 down at least one sideof container 32.

In one embodiment, an identification label can be a component separatefrom the other components including a sample shipping container. Inanother embodiment, an identification label is associated with a sampleshipping container as an integrated component. For example, referring toFIG. 10A-B, identification label 120 comprising label side 122 andadhesive side 126 including adhesive (not shown) and protective covering128 is associated with or comprises sealing flap 86 of sample shippingcontainer 80. Once sample container 130 comprising a sample is placed insample shipping container 80, protective covering 128 from adhesive side126 of identification label 120 to expose an adhesive. Sealing flap 86comprising identification label 120 is then affixed to the sampleshipping container by securing exposed adhesive to rear side 84 ofsample shipping container 80.

Generally, the number of identification labels disclosed herein is equalto the number of sample container provided in a collection kit. Thus, inone embodiment, a collection kit disclosed herein that comprises onesample container will include one identification label. In anotherembodiment, a collection kit disclosed herein that comprises a pluralityof sample containers will include the same number of identificationlabels as the plurality of sample containers. In yet another embodiment,a collection kit disclosed herein that comprises, e.g. two samplecontainers will contain two identification labels, three samplecontainers will contain three identification labels, four samplecontainers will contain four identification labels, or five samplecontainers will contain five identification labels.

An identification label disclosed herein as it pertains to a collectionkit disclosed herein has several advantages over current CoC procedures.For example, by providing an identification label a collection kitdisclosed herein dispenses with the need of hard-copy CoC forms. Inaddition, an identification label disclosed herein is compatible withall software systems used to initiate a COC procedure and dispenses withthe need to print out a tracking label. Furthermore, an identificationlabel disclosed herein facilitates tracking of document failures, suchas, e.g., incorrect or incomplete collection, handling or processingirregularities, thereby ensuring compliance with required or otherwisespecified CoC procedures determined by a governing authority.

Aspects of the present specification disclose a sample, e.g., sample 70of FIGS. 7, 8 , & 11B. A sample can be a biological sample or anon-biological sample. A sample can be a non-hazardous material or ahazardous material such as, e.g., an infectious, a toxic, a radioactiveor other bio-hazardous material. Non-limiting examples of a biologicalsample include urine, fecal matter, hair, blood, saliva, skin/epidermalcells, muscle, an internal organ, a pathogen, a plant or materialderived or collected from a plant, or foodstuff. Non-limiting examplesof a non-biological sample include dirt, debris from an explosion oraccident, rocks, glass, water, oil, gas or other petroleum product, afossil or any other non-biological material that can be procured off ofan individual, apparatus or location and collected as a sample disclosedherein.

A sample disclosed herein can be a sample obtained from an individual,an apparatus, or a location. An individual can be a human or an animal.An animal includes, without limitation, a mammal, a bird, a reptile, anamphibian, or a fish. An apparatus includes, without limitation, amachine or device. A location can be a discriminate or indiscriminateindoor location, such as, e.g., inside a container, vehicle, building,or a discriminate or indiscriminate outdoor location, such as, e.g., astreet, park, forest, desert, ocean, sea, river or other waterway.

Aspects of the present specification disclose a collecting pouch.Referring to FIGS. 5 & 11 , a collecting pouch 40 or 140 disclosedherein is used to secure the one or more sample containers 30 or sampleshipping container 80 comprising sample 70 for transportation. As acollected sample could be considered a bio-hazard, a collecting pouchdisclosed herein helps prevent contamination of sample 70 from thecollection site to the testing facility as well as preventscontamination due to spillage sample 70. Thus, a collecting pouchdisclosed herein is designed in a manner that it can be sealed once theone or more sample contained are placed inside the pouch (FIG. 8 ). Forexample, a collecting pouch can comprise a flap with an adhesive or aninterlocking groove and ridge that forms a tight seal when pressedtogether, thereby closing the pouch opening. In one embodiment, andreferring to FIG. 5 , a collecting pouch 40 disclosed herein comprises apouch 42 and a flap 44. In another embodiment, and referring to FIG. 12, a collecting pouch 140 disclosed herein comprises a pouch 142 and aflap 144. Collecting pouch 40, 140, can also optionally include adesignated spot to affix identification label 20 as well as optionallyincluding a designated spot to indicate testing facility address and/orbiohazard markings.

Aspects of the present specification disclose instructions. Instructionsdisclosed herein provide information to the individual who is donating abiological sample and/or a collector who is monitoring and/or sendingthe collected samples to a testing facility. In one embodiment,step-by-step instructions pertaining to the use of the componentscomprising kit for the collection of a biological sample. For example,information can include instructions to a donor in how to provide abiological sample for testing, such as, e.g., how to check the integrityof a collection kit and the components therein, how to preventcontamination of a biological sample during collection, how to preparehis/her person for obtaining a biological sample, how to collect abiological sample using a sample collection device, and how to aliquot abiological sample to one or more sample containers. Information caninclude instructions to a collector in how to administer the collectionand transportation of a biological sample from a donor, such as, e.g.,how to check the integrity of a collection kit and the componentstherein, how to prevent contamination of a biological sample duringcollection, how to observe the donor for proper collection of abiological sample, how to affix the identification labels to each samplecontainer, how to package the sample containers in collecting poach, andhow to package a biological sample for transportation to a testingfacility. Instructions disclosed herein can be provided together orseparately, e.g., an instruction sheet for a donor and a separateinstruction sheet for a collector. In addition, instructions can beseparated based on gender. i.e., separate instructions for a male donorand a female donor.

Aspects of the present specification disclose a cleaning wipe. Acleaning wipe disclosed herein is used to prepare the person of a donorto ensure proper collection of a biological sample that maintains itsintegrity and avoids contamination. Non-limiting examples of a cleaningwipe include a cloth material, a cotton ball or a paper towel and ofwhich can be presoaked with an alcohol, such as ethanol or isopropanol.In an aspect of this embodiment, and referring to FIG. 6 , cleaning wipe50 is a cloth material. A cleaning wipe can be in its own container tokeep it sanitary and can be saturated with a cleaning or disinfectantsolution, such as an alcohol. In an aspect of this embodiment, andreferring to FIG. 13 , cleaning wipe 150 is an alcohol wipe sealed in apouch.

The present specification also discloses methods and uses for collectinga biological sample using a collection kit disclosed herein. In oneembodiment, methods and uses disclosed herein are for collecting abiological sample from a human. In another embodiment, methods and usesdisclosed herein are for collecting a biological sample from an animal.

In one embodiment, a method comprises collecting a biological samplefrom an individual using a collection kit disclosed herein. In aspectsof this embodiment, a method comprises collecting a biological samplefrom an individual using a collection kit disclosed herein and affixingan identification label provided by the kit to each of the one or moresample containers comprising a sample. In other aspects of thisembodiment, a method comprises collecting a biological sample from anindividual using a collection kit disclosed herein, affixing anidentification label provided by the kit to each of the one or moresample containers comprising a sample and associating information on theoriginating source or the sample and/or testing instructions with theidentification label. In yet other aspects of this embodiment, a methodcomprises collecting a biological sample from an individual using acollection kit disclosed herein, affixing an identification labelprovided by the kit to each of the one or more sample containerscomprising a sample, associating information on the originating sourceor the sample and/or testing instructions with the identification label,and transporting the collected biological sample to a testing facilityfor analysis.

In one embodiment, a collection kit disclosed herein is used forcollecting a biological sample from an individual. In aspects of thisembodiment, a collection kit disclosed herein is used for collecting abiological sample from an individual and affixing an identificationlabel provided by the kit to each of the one or more sample containerscomprising a sample. In other aspects of this embodiment, a collectionkit disclosed herein is used for collecting a biological sample from anindividual, affixing an identification label provided by the kit to eachof the one or more sample containers comprising a sample and associatinginformation on the originating source or the sample and/or testinginstructions with the identification label. In yet other aspects of thisembodiment, a collection kit disclosed herein is used for collecting asample from an individual, affixing an identification label provided bythe kit to each of the one or more sample containers comprising asample, associating information on the originating source or the sampleand/or testing instructions with the identification label, andtransporting the collected biological sample to a testing facility foranalysis.

A collection kit or sample container disclosed herein can for medical orveterinary purposes. A medical or veterinary purpose includes drugtesting, genotype testing, disease testing, or biomarker testing. Acollection kit or sample container disclosed herein can also be used forcriminal, forensic or archaeological purposes or any other purpose whereaccurate CoC procedures are required or desired. A collection kit orsample container disclosed herein can also be used for universalpurposes such as analysis of material or chemical make-up related tomolecular composition or properties such as toxicology, viscosity,hysteresis and other related findings.

Aspects of the present specification can also be described as follows:

-   -   1. A kit for collecting a biological sample, the kit comprising        a sample collection device and one or more other components,        wherein the one or more other components comprise one or more        identification labels, wherein the one or more identification        labels each comprise one or more machine-readable codes with        unique identification characteristics on one side and an        adhesive on the other side.    -   2. The kit according to embodiment 1, wherein the sample        collection device serves as a container for the one or more        other components.    -   3. The kit according to embodiment 1 or 2, wherein the sample        collection device has a cylindrical cup-shaped design with a        capacity to hold between 100 mL to 400 mL.    -   4. The kit according to embodiment 3, wherein the sample        collection device has a cylindrical cup-shaped design with a        capacity to hold between 200 mL to 250 mL.    -   5. The kit according to any one of embodiments 1-4, wherein the        machine-readable code comprises a bar code, a matrix code or        two-dimensional bar code, a radio frequency identification        (RFID), a magnetic strip, a microchip, or an optical character        recognition (OCR).    -   6. The kit according to any one of embodiments 1-5, wherein the        one or more other components comprise one or more sample        containers, the one or more sample containers each comprising a        container and a lid.    -   7. The kit according to embodiment 6, wherein each of the one or        more identification labels is integrated onto the lid.    -   8. The kit according to embodiment 6, wherein the one or more        sample containers each have a cylindrical cup-shaped design with        a capacity to hold between 20 mL to 40 mL.    -   9. The kit according to embodiment 6, wherein the kit comprises        one to five sample containers.    -   10. The kit according to any one of embodiments 1-9, wherein the        one or more other components comprise a collecting pouch.    -   11. The kit according to any one of embodiments 1-10, wherein        the one or more other components comprise instructions.    -   12. The kit according to embodiment 11, wherein the instructions        pertain to the use of the components comprising kit for the        collection of a biological sample and/or pertain to the        collection and transportation of a biological sample obtained        from a donor.    -   13. The kit according to any one of embodiments 1-12, wherein        the one or more other components comprise a cleaning wipe.    -   14. The kit according to any one of embodiments 1-13, wherein        the sample is collected from an individual, an apparatus, a        location, or any combination thereof.    -   15. The kit according to any one of embodiments 1-14, wherein        the sample is a biological sample, a non-biological sample, or        both.    -   16. A method of collecting a sample, the method comprising        collecting a sample using a kit comprising a sample collection        device, one or more identification labels, each identification        label comprising one or more machine-readable codes with unique        identification characteristics, one or more sample containers, a        collecting pouch, instructions and a cleaning wipe, wherein the        sample is collected using the sample collection device.    -   17. The method according to embodiment 16, wherein the method        further comprises affixing an identification label from the one        or more identification labels to each of the one or more sample        containers comprising a sample.    -   18. The method according to embodiment 17, wherein the method        further comprises associating information on the originating        source or the sample and/or testing instructions with the        machine-readable code contained on the one or more        identification labels.    -   19. The method according to embodiment 18, wherein the method        further comprises transporting the collected sample to a        facility for subsequent testing or analysis.    -   20. The method according to any one of embodiments 16-19,        wherein the sample is obtained from urine, hair, blood, saliva        or skin/epidermal cells.    -   21. The method according to any one of embodiments 16-20, used        for a medical purpose, a veterinary purpose, a criminal        investigatory purpose, a forensic purpose, an environmental        evaluation purpose, or an archaeological purpose    -   22. A kit for use in collecting a sample from an individual,        wherein the kit comprising a sample collection device, one or        more identification labels, each identification label comprising        a machine-readable code with unique identification        characteristics, one or more sample containers, a collecting        pouch, instructions and a cleaning wipe, wherein the sample is        collected using the sample collection device.    -   23. A kit for collecting a sample, the kit comprising a        collecting pouch and one or more other components, wherein the        one or more other components comprise a sample shipping        container, the sample shipping container being a mailing        envelope with a sealing flap; and one or more identification        labels, the one or more identification labels each comprising a        machine-readable code with unique identification characteristics        on one side and an adhesive on the other side.    -   24. The kit according to embodiment 23, wherein the collecting        pouch serves as a container for the one or more other        components.    -   25. The kit according to embodiment 23 or 24, wherein the        machine-readable code comprises a bar code, a matrix code or        two-dimensional bar code, a radio frequency identification        (RFID), a magnetic strip, a microchip, or an optical character        recognition (OCR).    -   26. The kit according to any one of embodiments 23-25, wherein        the one or more sample containers is a flat sheet of aluminum.    -   27. The kit according to any one of embodiments 23-26, wherein        each of the one or more identification labels is integrated onto        the sealing flap.    -   28. The kit according to any one of embodiments 23-27, wherein        the one or more other components comprise instructions.    -   29. The kit according to embodiment 28, wherein the instructions        pertain to the use of the components comprising kit for the        collection of a sample and/or pertain to the collection and        transportation of a sample obtained from a donor or objects or        materials at collection site.    -   30. The kit according to any one of embodiments 23-29, wherein        the one or more other components comprise a cleaning wipe.    -   31. The kit according to any one of embodiments 23-30, wherein        the sample is collected from an individual, an apparatus, a        location, or any combination thereof.    -   32. The kit according to claim 23, wherein the sample is a        biological sample, a non-biological sample, or both.    -   33. A sample container comprising a container, a lid and an        identification labels, the identification label comprising one        or more machine-readable codes with unique identification        characteristics on one side and an adhesive on the other side,        wherein the identification label has a portion affixed to the        lid and one or more portions unassociated with the sample        container, the side having the adhesive of one or more        unassociated portions being covered by a protective covering,        the protective covering optionally comprising a tab.    -   34. The sample container according to embodiment 33, wherein the        machine-readable code comprises a bar code, a matrix code or        two-dimensional bar code, a radio frequency identification        (RFID), a magnetic strip, a microchip, or an optical character        recognition (OCR).    -   35. The sample container according to embodiment 33 or 34,        wherein the sample container has a cylindrical cup-shaped design        with a capacity to hold between 20 mL to 40 mL.

In closing, it is to be understood that although aspects of the presentspecification are highlighted by referring to specific embodiments, oneskilled in the art will readily appreciate that these disclosedembodiments are only illustrative of the principles of the subjectmatter disclosed herein. Therefore, it should be understood that thedisclosed subject matter is in no way limited to a particular compound,composition, article, apparatus, methodology, protocol, and/or reagent,etc., described herein, unless expressly stated as such. In addition,those of ordinary skill in the art will recognize that certain changes,modifications, permutations, alterations, additions, subtractions andsub-combinations thereof can be made in accordance with the teachingsherein without departing from the spirit of the present specification.It is therefore intended that the following appended claims and claimshereafter introduced are interpreted to include all such changes,modifications, permutations, alterations, additions, subtractions andsub-combinations as are within their true spirit and scope.

Certain embodiments of the present invention are described herein,including the best mode known to the inventors for carrying out theinvention. Of course, variations on these described embodiments willbecome apparent to those of ordinary skill in the art upon reading theforegoing description. The inventor expects skilled artisans to employsuch variations as appropriate, and the inventors intend for the presentinvention to be practiced otherwise than specifically described herein.Accordingly, this invention includes all modifications and equivalentsof the subject matter recited in the claims appended hereto as permittedby applicable law. Moreover, any combination of the above-describedembodiments in all possible variations thereof is encompassed by theinvention unless otherwise indicated herein or otherwise clearlycontradicted by context.

Groupings of alternative embodiments, elements, or steps of the presentinvention are not to be construed as limitations. Each group member maybe referred to and claimed individually or in any combination with othergroup members disclosed herein. It is anticipated that one or moremembers of a group may be included in, or deleted from, a group forreasons of convenience and/or patentability. When any such inclusion ordeletion occurs, the specification is deemed to contain the group asmodified thus fulfilling the written description of all Markush groupsused in the appended claims.

Unless otherwise indicated, all numbers expressing a characteristic,item, quantity, parameter, property, term, and so forth used in thepresent specification and claims are to be understood as being modifiedin all instances by the term “about.” As used herein, the term “about”means that the characteristic, item, quantity, parameter, property, orterm so qualified encompasses a range of plus or minus ten percent aboveand below the value of the stated characteristic, item, quantity,parameter, property, or term. Accordingly, unless indicated to thecontrary, the numerical parameters set forth in the specification andattached claims are approximations that may vary. For instance, as massspectrometry instruments can vary slightly in determining the mass of agiven analyte, the term “about” in the context of the mass of an ion orthe mass/charge ratio of an ion refers to +/−0.50 atomic mass unit. Atthe very least, and not as an attempt to limit the application of thedoctrine of equivalents to the scope of the claims, each numericalindication should at least be construed in light of the number ofreported significant digits and by applying ordinary roundingtechniques.

Use of the terms “may” or “can” in reference to an embodiment or aspectof an embodiment also carries with it the alternative meaning of “maynot” or “cannot.” As such, if the present specification discloses thatan embodiment or an aspect of an embodiment may be or can be included aspart of the inventive subject matter, then the negative limitation orexclusionary proviso is also explicitly meant, meaning that anembodiment or an aspect of an embodiment may not be or cannot beincluded as part of the inventive subject matter. In a similar manner,use of the term “optionally” in reference to an embodiment or aspect ofan embodiment means that such embodiment or aspect of the embodiment maybe included as part of the inventive subject matter or may not beincluded as part of the inventive subject matter. Whether such anegative limitation or exclusionary proviso applies will be based onwhether the negative limitation or exclusionary proviso is recited inthe claimed subject matter.

Notwithstanding that the numerical ranges and values setting forth thebroad scope of the invention are approximations, the numerical rangesand values set forth in the specific examples are reported as preciselyas possible. Any numerical range or value, however, inherently containscertain errors necessarily resulting from the standard deviation foundin their respective testing measurements. Recitation of numerical rangesof values herein is merely intended to serve as a shorthand method ofreferring individually to each separate numerical value falling withinthe range. Unless otherwise indicated herein, each individual value of anumerical range is incorporated into the present specification as if itwere individually recited herein.

The terms “a,” “an,” “the” and similar references used in the context ofdescribing the present invention (especially in the context of thefollowing claims) are to be construed to cover both the singular and theplural, unless otherwise indicated herein or clearly contradicted bycontext. Further, ordinal indicators—such as “first,” “second,” “third,”etc.—for identified elements are used to distinguish between theelements, and do not indicate or imply a required or limited number ofsuch elements, and do not indicate a particular position or order ofsuch elements unless otherwise specifically stated. All methodsdescribed herein can be performed in any suitable order unless otherwiseindicated herein or otherwise clearly contradicted by context. The useof any and all examples, or exemplary language (e.g., “such as”)provided herein is intended merely to better illuminate the presentinvention and does not pose a limitation on the scope of the inventionotherwise claimed. No language in the present specification should beconstrued as indicating any non-claimed element essential to thepractice of the invention.

When used in the claims, whether as filed or added per amendment, theopen-ended transitional term “comprising”, variations thereof such as“comprise” and “comprises”, and equivalent open-ended transitionalphrases thereof like “including,” “containing” and “having”, encompassesall the expressly recited elements, limitations, steps, integers, and/orfeatures alone or in combination with unrecited subject matter; thenamed elements, limitations, steps, integers, and/or features areessential, but other unnamed elements, limitations, steps, integers,and/or features may be added and still form a construct within the scopeof the claim. Specific embodiments disclosed herein may be furtherlimited in the claims using the closed-ended transitional phrases“consisting of” or “consisting essentially of” (or variations thereofsuch as “consist of”, “consists of”, “consist essentially of”, and“consists essentially of”) in lieu of or as an amendment for“comprising.” When used in the claims, whether as filed or added peramendment, the closed-ended transitional phrase “consisting of” excludesany element, limitation, step, integer, or feature not expressly recitedin the claims. The closed-ended transitional phrase “consistingessentially of” limits the scope of a claim to the expressly recitedelements, limitations, steps, integers, and/or features and any otherelements, limitations, steps, integers, and/or features that do notmaterially affect the basic and novel characteristic(s) of the claimedsubject matter. Thus, the meaning of the open-ended transitional phrase“comprising” is being defined as encompassing all the specificallyrecited elements, limitations, steps and/or features as well as anyoptional, additional unspecified ones. The meaning of the closed-endedtransitional phrase “consisting of” is being defined as only includingthose elements, limitations, steps, integers, and/or featuresspecifically recited in the claim whereas the meaning of theclosed-ended transitional phrase “consisting essentially of” is beingdefined as only including those elements, limitations, steps, integers,and/or features specifically recited in the claim and those elements,limitations, steps, integers, and/or features that do not materiallyaffect the basic and novel characteristic(s) of the claimed subjectmatter. Therefore, the open-ended transitional phrase “comprising” (andequivalent open-ended transitional phrases thereof) includes within itsmeaning, as a limiting case, claimed subject matter specified by theclosed-ended transitional phrases “consisting of” or “consistingessentially of.” As such embodiments described herein or so claimed withthe phrase “comprising” are expressly or inherently unambiguouslydescribed, enabled and supported herein for the phrases “consistingessentially of” and “consisting of.”

All patents, patent publications, and other references cited andidentified in the present specification are individually and expresslyincorporated herein by reference in their entirety for the purpose ofdescribing and disclosing, for example, the compositions andmethodologies described in such publications that might be used inconnection with the present invention. These publications are providedsolely for their disclosure prior to the filing date of the presentapplication. Nothing in this regard is or should be construed as anadmission that the inventors are not entitled to antedate suchdisclosure by virtue of prior invention or for any other reason. Allstatements as to the date or representation as to the contents of thesedocuments is based on the information available to the applicant anddoes not constitute any admission as to the correctness of the dates orcontents of these documents.

Lastly, the terminology used herein is for the purpose of describingparticular embodiments only and is not intended to limit the scope ofthe present invention, which is defined solely by the claims.Accordingly, the present invention is not limited to that precisely asshown and described.

The invention claimed is:
 1. A kit for collecting a sample, the kitcomprising: one or more identification labels, a sample collectiondevice, one or more sample containers, each of the one or more samplecontainers having a lid, and a collecting pouch; each of the one or moreidentification labels comprising one or more machine-readable codes withunique identification characteristics on one side and an adhesive on theother side; the sample collection device being configured to collect thesample from a sample source and dispense the sample into the one or moresample containers; each of the one or more sample containers beingconfigured to receive therein the sample dispensed from the samplecollection device; and the collecting pouch configured to secure the oneor more sample containers for transportation; wherein each of the one ormore identification labels is secured onto the lid of each of the one ormore sample containers using the adhesive side, each of the one or moreidentification labels having one or more portions of the adhesive sidethat remain unassociated with the lid, the one or more unassociatedportions of the adhesive side being covered with protective coveringthat can optionally comprise one or more tabs, the one or moreunassociated portions being configured to affix to a side of a samplecontainer from the one or more sample containers once the lid is securedto the sample container and the protective covering is removed from oneor more unassociated portions of the adhesive side; and wherein thesample collection device contains the one or more identification labels,the one or more sample containers and the collecting pouch within thesample collection device, the sample collection device configured with aremovable seal that prevents access and removal of the one or moreidentification labels, the one or more sample containers, and thecollecting pouch contained therein until the removable seal is pulledoff.
 2. The kit according to claim 1, wherein the sample collectiondevice has a cylindrical cup-shaped design with a capacity to holdbetween 100 mL to 400 mL.
 3. The kit according to claim 2, wherein thesample collection device has a cylindrical cup-shaped design with acapacity to hold between 200 mL to 250 mL.
 4. The kit according to claim1, wherein the machine-readable code comprises a bar code, a matrix codeor two-dimensional bar code, a radio frequency identification (RFID), amagnetic strip, a microchip, or an optical character recognition (OCR).5. The kit according to claim 1, wherein the one or more samplecontainers each have a cylindrical cup-shaped design with a capacity tohold between 20 mL to 40 mL.
 6. The kit according to claim 1, whereinthe kit comprises one to five sample containers.
 7. The kit according toclaim 1, wherein each of the one or more identification labels includeserialized machine-readable codes in consecutive order that facilitatedata reporting and tracking with respect to inventory usage.
 8. The kitaccording to claim 1, further comprising a set of instructionsconfigured to be sealed within the sample collection device.
 9. The kitaccording to claim 8, wherein the set of instructions pertain to the useof the kit for the collection of a biological sample and/or pertain tothe collection and transportation of a biological sample obtained from adonor.
 10. The kit according to claim 1, further comprising a cleaningwipe configured to be sealed within the sample collection device. 11.The kit according to claim 1, wherein the sample source is anindividual, an apparatus, a location, or any combination thereof. 12.The kit according to claim 1, wherein the sample is a biological sample,a non-biological sample, or both.
 13. The kit according to claim 1,wherein each of the one or more identification labels is configured tohave a first machine-readable code and a second machine-readable code,wherein the first and second machine-readable codes are different typesof machine-readable code.
 14. The kit according to claim 1, wherein thefirst machine-readable code is provided at a medial location of each ofthe one or more identification labels and the second machine-readablecode is provided at a location lateral to the medial location of thefirst machine-readable code.
 15. A kit for collecting a sample, the kitcomprising: one or more sample containers, each of the one or moresample containers composed of a malleable or pliable, non-elasticmaterial, the one or more sample containers configured to receive andwrap or otherwise contain therein the sample; a sample shippingcontainer, the sample shipping container being a mailing envelope with asealing flap; one or more identification labels, the one or moreidentification labels each comprising a machine-readable code withunique identification characteristics on one side and an adhesive on theother side, each of the one or more identification labels is integratedonto the sealing flap; and a collecting pouch, the collecting pouchconfigured to contain the one or more sample containers, the sampleshipping container, and the one or more identification labels, whereinthe collecting pouch contains the one or more sample containers, thesample shipping container, and the one or more identification labels,the collecting pouch configured with a perforated top sealing thecollecting pouch and prevent access and removal of the one or moresample containers, the sample shipping container, the one or moreidentification labels contained therein until the collecting pouch isopened, the perforated top having a zip-lock seal configured to resealthe collection pouch after the perforated top is opened.
 16. The kitaccording to claim 15, wherein the one or more sample containers is aflat sheet of aluminum.
 17. The kit according to claim 15, wherein thesample is collected from an individual, an apparatus, a location, or anycombination thereof.
 18. The kit according to claim 15, wherein thesample is a biological sample, a non-biological sample, or both.